FDA approves heavy anti-cancer target drug Daretou monoderinoma subcutaneous injection sis! The administration was reduced from 3 hours to 5 minutes!

On May 1, 2020, the FDA approved the subcutaneous injection sisyds of daratumab (Chinese product names: ®, Darzalex, daretoumonotag) and hyaluronic acid enzyme-fihpro for adult patients with newly diagnosed or recurrent/refractive multiple myelomaThe dosage form is developed using Halozyme's ENHANZE drug delivery technology and contains recombinant human hyaluronic acid asse PH20 (rHuPH20)currently listed Darzalex is an intravenous (IV) preparationToday's approved subcutaneous injection sedatives have the same efficacy as existing IV formulations, and reduce the incidence of infusion-related reactions, significantly reducing the time patients receive treatment, from a few hours to about 5 minutesThe approval is based on the results of the3 COLUMBA (MMY3012) study, which is no less effective than daratumumab intravenous preparationsthe trial was conducted in patients with multiple myeloma who had previously received at least three treatment options (including protease inhibitors (PI), immunomodulators (IMiD)) or multiple myeloma patients who were difficult to treat for PI and IMiD, comparing the non-toxicefficacy of daratumumumab subcutaneous and daratumumumab intravenous agents263 patients received daratumumab subcutaneous preparations and 259 patients were treated with intravenous daratumabThe uniform dose for the subcutaneous injection group was 1800 mg and the intravenous agent was 16 mg / kgDouble-weekly double-weekly treatment in the first two cycles, followed by treatment every 2 weeks in cycles 3-6, from cycle 7 to disease progression, and every 4 weeksresults showed that daratumumab subcutaneous and intravenous preparations had non-poor efficacy (total mitigation rate: 41.1% vs 37.1%) and pharmacokinetics, while shorter drug administration took less time (5 minutes vs 3 hours or more) and had a lower incidence of infusion-related reactions (13% vs 35%), the results of the ongoingPLEIADES (MMY2040) Phase 2 test(NCT034125555) also support this approvalincluded 240 adults with newly diagnosed or recurrent/refractive multiple myeloma in the non-random, open-labeled, parallel-distributed PLEIADES 2 study Patients initially diagnosed with the disease were injected with daratumab, combined with boratizomi, reinamine and desecetamsone (D-VRd) or boratizomi, mefalon and d-VMP Treatment of hypocutanulamine/desecetamsone (D-Rd) in patients with recurrent/incurable disease results show that the objective mitigation rate (ORR) in the D-VMP queue is 88.1% The ORR in the D-Rd group was 90.8 percent and the ORR in the D-VRd group was 97 percent at present, daratumab has become an important basic drug option for the treatment of multiple myeloma (MM) In the United States, seven treatments have been approved, three of which are first-line therapeutic indications The drug was approved for sale in China in October 2019 this approved Daratumab and hyaluronic acid-fihj indications cover the following indications of previously approved intravenous preparations daratumab : with boratizomi, mefalon and pernison combined with patients with multiple myeloma not suitable for self-contained stem cell transplantation for the new diagnosis; in conjunction with naratallamine and dexamethasone for newly diagnosed patients who are not suitable for autologous stem cell transplantation and patients with recurrent or refractory multiple myeloma who have received at least one previous treatment; in conjunction with bopentizomi and dexamethasone for patients with multiple myeloma who have received at least one previous treatment; and as a single therapy for at least three previous treatments, including protein inhibitors and immunotherapy daratumab is a CD38 mediated, lysozymatic antibody drug with broad-spectrum killing activity, can target trans-diaphylase CD38 molecules highly expressed on the surface of multiple myeloma and multiple solid tumor cells, and induces rapid death of tumor cells through a variety of immune mediated mechanisms, including complementary-dependent celltoxicity (CDC), antibody-dependent cell-mediated cytotoxic (ADCC) and antibody-dependent phagocytose (ADD) and antibody-dependent phagocytosis In addition, daratumumab has been shown to target immunosuppressive cells in tumor microenvironments to show immunomodulation According to the FDA, "the recommended use of daratumumab and hyaluronic acid asse-fihj is injected into the abdomen in about 3-5 minutes with 1800 mg daratumab and 30,000 units of hyaluronic acid asse." "
Source: Network